AU2010343123B2

AU2010343123B2 - Medical instrument with probe, probe cover, and methods of using the same

Info

Publication number: AU2010343123B2
Application number: AU2010343123A
Authority: AU
Inventors: John A. Lane; David E. Quinn; Ray D. Stone
Original assignee: Welch Allyn Inc
Current assignee: Welch Allyn Inc
Priority date: 2009-12-30
Filing date: 2010-12-22
Publication date: 2015-05-07
Anticipated expiration: 2030-12-22
Also published as: CN102770175B; US20130131518A1; WO2011090670A3; US8374683B2; US9282883B2; AU2010343123A1; WO2011090670A2; EP2519301A4; CN102770175A; US20110160595A1; US20160151019A1; EP2519301A2; EP2769747A1; EP2519301B1

Abstract

A medical instrument including a probe adapted to be inserted into an orifice of an animal's body. The instrument includes an emitter of electromagnetic radiation that is sensed by a sensor mounted on the probe. The sensor can then determine, by variations in the amount of radiation received from the emitter, whether a probe cover is mounted over the probe. A sensor can also be used to determine whether the walls of the body orifice block the radiation received from the emitter, thereby indicating position of the sensor, and thus, the probe within the orifice. A special probe cover is disclosed, and methods of using the medical instrument are also disclosed.

Description

WO 2011/090670 PCT/US2010/061715 MEDICAL INSTRUMENT WITH PROBE, PROBE COVER, AND METHODS OF USING THE SAME FIELD OF THE INVENTION [0001] The present invention relates a medical instrument with a probe adapted to be inserted into an orifice in an animal's body, such as an animal's ear. In one aspect of the invention the medical instnrinent includes a system for detennfining the status of a probe covet: adapted txo be mounted over the probe, and in another aspect, the invention relates to a system for detennining the depth of insertion of the probe i nto the oi fice. BACKGROUND OF THE INVENTION [0002] Medical insIruments are often inserted into body orifices in order o e>xamiiine the conditions of internal body tissue and other. body conditions, to apply medicines, and for other purposes. Iypically, such medical instAruments micludeC a probe having a 'generally conical peripheral configuration that is inserted into the orifice and that usually is seated against the walls of the orifice. Such medical instrunents include ear instruments such as, for example, otoscopes for examining a patient's ear, infrared thermomeers for measuring the temperature of an ear drum, and tympianometers. [00031 Medical instruments that are adapted to he inserted into a body orifice are usually expensive and miust be reused. The probe section of the medical instrument that is adapted to be inserted into the orifice may be contaminated Witli body fluids, wax, hair, and skin cells. By reusing the medical instrumeiit such contaminates may be transmitted to other patients, which naturally may result in the transmission of disease or other undesirable effects. In order to provide for sanitary reuse of such med ical instruments, disposable probe covers have been uitilized. Such 1 WO 2011/090670 PCT/US2010/061715 probe covers are tyIpicaly hollow and usually possess a configuration conforming to that of the associated probe. Probe covers may be selectively mounted to the medical inStrumem. in a position mounted over aCI arontTd rhe probe, such as by a compressive snap fit or by a threadable connection. After using the medical instrument with ithc probe cover in connection with one patient, the probe cover is detached Fromi the tmied ical instrument and permane ndy discarded .\ new probe cover is then mnounrited over the probe and selecuively attached to the medical in strumenIt heiore the medical instrument is reused with alnlether pati.en t. [00041 Smeiimes a healthca re praciiioner may incorrecdy prestime that a probe cover mnounied on the medical instrument is a fresh probe cover rather than oneti that Ihas al-cady been used. In stch even, the probe cover may transtnt cilltninants to the next patient t on wv hich the mtledical instrumen t is used . :\spect s of ihe present iiive 1 nt n were developed in-1 res po nse i concerns ab on t cross contamination (i it er 11 ant refuse of a pr obe covcr. 100051 Anote r aspect of the presetit invention is directed il determning a depth fl insertion of the probe and probe covet, and preferably whether the prol and probe cover have. achieved a minirnal or preferred depthI of insertion when instead inito I body orifice, sunchI as al ear. In this regard. aspects of the current invention aliment 1cthe reaching disclosed in Applicant's co-pending U.S. Scrial No. 12/610,760 entitled "'TE FRiM IM ET I R FOR D IE' RM I NING THI TI MPhEl'RATURE OF AN ANIMAL'S FAR DRUM AND MTHIOl -l()D OF USING SAME",tFled Noveiber 2 , e disclosure of which is hereby incorploirated reference. 100061 Inl order t) petformb some prtoceduIes, the mn edic:i ins trunmetit will not properly function unless the probe is inserted to a sufcient depth. to an ideal depth. into a body orifice. Thereflore it is important to determine the depth of insertion if Ile probe and any probe cover as a rnedical instrumietl is being used,! iln order to 2 WO 2011/090670 PCT/US20101061715 inls ure ilhat the cncd ica I i nstrumnt iS :1cer impli Sh ing l 11S, 1RAdedCL itilpOSC. bil examl le, 'IS t'xplained in) mar-t:x dettail in the p.tex'itiily tilIti nttld co-p1cndin7g patent appica tionl I. whel i mca,1-i rg the ofpe~ir it n animal s en r drirt n haseri u pon r h inii eired radija rn i emitcl by 117 1 . c v ii al. (it-Lrn. it itz 1111p i arit 11:1 t hi:Ile p tiobc be i tisc c l a ~ ~ ~ _ tFtci CtlC6 oi : nr51ih SC Ilyk 4:n1!1V illrtared radiation elirtted bil rhc gon av un tilhe earI druml' is regis te red, itihe p i-oe o is uh ciet i isytc n the Car, then thle infrared dienriomete: will wceeive infrared radiation from uther areas of the car canal and the outer car that do not accurately indicate the temperature, tf ilhe cat drum.ll '11C. meIdical instrument oC tle~ present Invention im also be uWcd 10 delexnmne thle depth of insertion of thle probe anid ally probe cover. SUMMARY OF T[1WF INVE NTION 100071 T he present iventrion tet(- o ts ic the md al in Sit utfltiIt inclitiing aj ptlteb tdapck ted b c iliscried into anl on ifiee of :nt atlinitnls body.. *].*he ills trtuteIlI ticliles;:Ilirit licr oe f eleerrot~incil te rdlmilra that Is scltscd 1' :I scils, mionted oil dhe proble. T he seistr uIlltitlcil detviltminc. by ca 111:11tr n's inl thc atmiuli. at ta dii iot received tromrtht ie ait ter, kNwhether a pro be er teen is ti outintd over thle p 10ibc. A setso r canl als )o used to c tcrmnc the e, Wfl M to whiCh 111 lie 11 Of ii s (t'. bod v onifiee block dt e rad iano ticmrceived hl-om thle emitter, the rcl) inclic'ttiltile Position (it' thle Sensor. :in1i titus. the position of thle probe \vithin thle orifice. A ., . al pr-obe coet-c is. di sciii red, and -nrnctbds af ITIS itig rh e toeclCal i tIrtnemraeaso [0008] hit ote errllbodimnent, the irole cover is fashioned ofi .utttrei:iI. rieatcd tvilh a coatring, 0l . ,1 tewise cisued i)rt-1:1ialhIc In 1Sanitrm ia tiot I.Vithin U selected iiiittii id i.l T7he band width of partial t rart Sl sita 37ce Inna bch selected to be wit bitt, Ccidelitle -)1.ccvtrn p ;Ibtic id 1 th of r c bric! ll tmell sC i 1:1 ii etillint b. ri le 3 [0009] In other embodiments, the invention includes a microprocessor with a timer that is programmed either to generate a signal or to disable the instrument if a minimum time interval has passed since the probe cover was mounted over the probe and the sensor has not sensed the removal of the probe cover. If the system detects that the probe cover has been inserted into a body orifice by blockage of the radiation sensed by the sensor, then the microprocessor may be programmed either to generate a signal or to disable the instrument if a minimum time interval has passed since the insertion and the sensor has not sensed the removal of the probe cover. [0009a] In other embodiments the invention includes a medical instrument including: a support structure; a probe attached on said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; a probe cover adapted to be selectively mounted over and to substantially cover said probe and said sensor, said probe cover being partially transparent to said radiation such that when said probe cover substantially covers said probe, said sensor senses reduced transmittance of said radiation; and a microprocessor operatively connected to said sensor, said microprocessor configured to monitor the magnitude of said radiation sensed by said sensor and to evaluate the degree of any reduction of said monitored magnitude as an indication of the insertion of said probe into the body orifice. 4 [0009b] In other embodiments the invention includes a method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, comprising: (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; (4) a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; and (5) a probe cover adapted to be selectively mounted over and to substantially cover said probe, said probe cover being partially transparent to said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) monitoring the magnitude of said radiation sensed by said sensor; (e) establishing a threshold magnitude of said radiation; (f) setting a threshold time interval; and (g) determining that said probe cover is mounted over and substantially covers said probe if said monitored magnitude of said radiation is no more than said threshold magnitude during said threshold time interval. [0009c] In other embodiments the invention includes a method of determining the depth of insertion of a probe of a medical instrument into an orifice of a body, comprising: 4A (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; (4) a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) determining the magnitude of said radiation sensed by said sensor; (e) inserting said probe into the orifice; (f) monitoring the magnitude of said radiation sensed by said sensor as said probe is inserted into the orifice; and (g) evaluating whether the degree of any reduction of said monitored magnitude as said probe is inserted into the orifice indicates the extent to which said sensor has passed a wall of the orifice. [0009d] In other embodiments the invention includes a method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, comprising: (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said probe, said emitter mounted on said support structure; 4B (4) a sensor adapted to sense said radiation, said sensor mounted on said probe in a position so as to receive said radiation; and (5) a probe cover adapted to be selectively mounted over and to substantially cover said probe, said probe cover being partially transparent to said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) determining the magnitude of said radiation sensed by said sensor; (e) assessing whether the magnitude of said radiation sensed by said sensor drops by a magnitude that would indicate that said probe cover has been mounted to substantially cover said probe; and (f) if the magnitude assessment indicates that said probe cover has been mounted to substantially cover said probe, then making a later magnitude assessment of whether the magnitude of said radiation sensed by said sensor increases by a magnitude that would indicate that such probe cover has been unmounted from a disposition substantially covering said probe. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The invention will be described with reference to the accompanying drawings, wherein: FIG. 1 is a schematic side view of an otoscope in connection with which the present invention may be used; FIG. 2A and 2B are a schematic side view, and a schematic perspective view, respectively, of a probe cover that may be used in connection with the present invention; FIG. 3 is a schematic illustration of a probe in the otoscope shown on FIG. 1 in which an emitter of radiation is mounted on the head section of the otoscope, a sensor is mounted on the probe of the otoscope, and a probe cover as shown in FIGS. 4C 2A and 2B may be attached and detached from the otoscope in the directions shown by the indicated arrows; FIG. 4 is a schematic illustration of the probe and attached probe cover shown in FIG. 3 inserted into a human's ear canal; FIG. 5 is a schematic illustration of a side view of a probe on which a sensor according to one embodiment of the present invention is mounted; 4D WO 2011/090670 PCT/US2010/061715 1:K1 6 is a schematic illustration of a side view of a probe on which another sensor in accordance with anther eiboditent of the pirsent invention is mounted; FIM 7 is a schemntic illustrinion of a side view ol a probe on which another senso,0r in accordance with yet another embodiment of the present invention is mounnitfd 'and FIG. 8 is a block diagram of electrical inerconnections between various components of the medical instrument in accordance with an eibodinent of the present invention. DESCRIPTION OF A PREFERRED EMBODIMENT [0011] The present invention will be described with reference to the accompanying drawmgs wherein like reference numexals refer to the same item. It should be appreciated that rhe following description is intended to be exerplary only, and the scope of the invention envisions other varitions and inodifi ca tions of Ilese particular exempauy emnbodimtents. [0012] There shown in FK; I, in general illustration, a convcntio0nal otoscope 10 that may' be useful in connection with the present invention Ai ooscope is a device used to exa mitie and inspect the inner ear of a iuman t other animL Although in an exempt lart embodiment, reference is made to an 0toIscpe, it should be apprecia ted i otiter medical insirurnents. such as an infrared termnometer having a probe adapltd to being inserted into a hutna iar, also may be advantageously mpnt)loyed in connection with the present inventon. [00131 The mroscope 10 includes a handle 12. a neck 14, a head seectioN 6, and a probe IS. The neck 14 connects the head section 16 with the handle 12. Preferably, the neck 14 is constructed so dr the head section 16 may he selecively rated with respect to the handle 12 and may be selectively locked into a desired position of rotation by means of a clamr'ipintg screw 20. Tfhe probe 18 generally possesses a hollow 5 WO 2011/090670 PCT/US2010/061715 interior and both an interior and external frusto-conical configuration. The probe IS may be attached permanently or removably from a support structure such as, for example, the head section 10. [0014] The ornscope 10 typically has.a viewing lens system and a light illumination source disposed in the head secdon 16. Ie light source project ts ligt through the intcri5or of the probe 18, and illuminate the ear and car canal. Te handle section 12 may house batteries that are used to power the light source. A healthcare practitioner loOks through the lens system, through the interior of the probe 18, and to the illumninmeid rCA of the ear and ear canal. [00131 It will be appreciated ta t direct contact of the probe t8 vith the wall of teear and car can al will result in car wax or other residue accumulating on the periphery of the probe 18. Reusing ihe same probe 18 may transmit such car wax and other residue to another patient, which may result in the transission of disease or other adverse effect. The probe 38 may be cleaned and sanitized, however, errors may occur by firgctting the cleaning step, or by achiv ing oly incoiplete sanitatiot. Moreover, patients may be rectant to believe that the probe 18 has beeI sufficiently sanitized, aid therefore may be reluctant to allov the healthcare pacirioner to insert the probe I'S itt o their ears. 1001,6] 1In recognition if these sanitation cofnicems. disposable probe covers ate mounted rover It pre 1S an.id are rernovably attached to the head section 16. .n cxempliary probe covert 22 is shown in 1HG1 2A and 21 Ihe probe covet 22 is ashind as a holow tube. 1ypicaly, a probe cover 22 possesses a generally uniform thi ckiness, so that the exterior surface possesses a contiguration that is generally similar to te interior surface of the probe cover 22. The probe cover 22 may be retmovabl nttached to the head section 16 of the otoscope 10 such as triugh a snap fit conncction or through a threadable connection. le probe cover 22 shown in FIGS. 2A and 2B possesses a series of internal threads so that the probe cover 22 is 6 WO 2011/090670 PCT/US2010/061715 threadiblv, rcaleasably secured to the head section 16. For this puipose, the p robe cover 22 possesses a pair of opposing fins 24, 26 by which :i heahhcare practitioners ny imiualIV grasp and rotate rht: probe cover 22. The probe cover 22 is design ted fone-time use, antI is intended to be disposed in thu trash a fter use on a patient. 10017] 1IG. 4 illustrates how the probe cover 22 is typically inserted into a human's ear, and helps to highlight how car wasc and other residue may come into contact with the probe cover 22 and may be carried by the probe cover 22 after removal of die probe cover 22 from the car. [0018] Since probe covers are disposable, they provide more confidence that contamination will not be transrntted, however. there may be errors in making sure lia a probe cover is derached and disc rded after use on a patient. 100191 )tie aspect of ie prescint inv yentiin provides a safeguard for helping to insure thiat de medical inistrumnit, such :1 dhe otoscope U0, will no be reused on a diffeCrem ltieint with the same probe covcr. As sh wn n I IG. 3, i eminr 28 is preferably moiuIted on the head section 16 of the iioscope I0. The imitter 28 is capable of emi tting elero-magnetic radiation, which is directed r last itn part to a sensor 30 mioun Med on the outside periphery of the probe 18. Prererably thc electro imanete radia t io is differit:t fror sunlight or other ambi ient ight that might exist in a medical facility. The radiation need not he in the visiledr: sietrium, but preferably is within the visible spectruni. In a pre.feireid enbodimrent. the emitter comprises a blue .LID that emits visible light intensely in a bandwidth of approximately 500-550 nanometers of wavelength. *.he radiation inay be emitted continuously, or in pulses. 10020] When iic probe cover 22 is mounted ovetr and covers the. probe 18, and is detachably connected to the head section 16, radiation emitted by the emitter 28 ps,55 if at all, through the wall of probe cover 22 before reaching and being detected by the sensor 30. If the probe cove all 22 i not compIetely iransp:irent and nor comlipletely opalt: t) the radiation, the sensor 30 will be able to dcicer a redc tlion in 7 WO 2011/090670 PCT/US2010/061715 the amnoun itt of r adiationl being received from the emitter 28. In order vo help determinee h:t the reduction in radiation received hy the sensor 30 is due to mnitntng of the probe cover 22 over the probe I8, and is not due to human fingers, paper, or another object being imterposed in the panh hetween ih eemitter 28 and the sensor 30, the probe ovxer 22 may be selectively constructed with special characteristics that will help ens ure t at. the teduiction in se nsed radiation is due to tre mounting of the probe cover 22 over the probe IS. For e.xample, it may be desirable for the probe cover 22 to have known traismintnce in the range of ubout 40 to 60%, or abot 50%, within a pre(-determinted bandwidth. IIn order to aclieve s uch desirable transrrittancc the probe cover 22 may be fashioted of a parnilar type of translucent material and a particular thickness designed to achieve such desired transmittance. The material forming the probe cover 22 may also be impregnated with color or other nmt t erial inl order to :thieve such transmittance. Further, either the exterior surface, the interior surface, or both of the probe cover 22 may be coated with material that affects the reflectiont, absorption, and imatc transitatae of radiation impingilg thereon within a selcted landwidth. [021] T he invention tcotemplates rhat color filtrs such as those offered by Rosco L.aboratorries, Inlc. nlca ted in St:amiford, Cnctic ut may be etimployed with the probe cover 22. Such coI or filters incIuKide body-'ca ored color ftIters int which a cilorant is integrated within a phistic subtrte by mixiiing : dye into a meled resin, deepl)-dyed clr filters inl which a ceiratr poles ter sheet is passed throu, a heated solvent suffused with a ive, and surface cotted Color filers in which a colored mrtaterial is coatd.:i onto a pol-ester film base. [0022] iThe characteristics of the probe cover 22, especially any coatings applied to probe cover 22, may osess a unique fihering i of te radiation so tha only very firnhed handwidth of the radbion ei ed by te ermiter 28 is acmUally received by the sensor 30. In such an embodirment, the sensor 30 could also be p-rovided with 8 WO 2011/090670 PCT/US2010/061715 a corresponding filter so that the overall system will properly Function only if probe covers 22 having a similar filteing characteristic arce employed. Ihis process can be used to help insure that only specific types of probe covers 22 are utilized in connection with the otcscopc 10. [0023] It will also he appreciated dat whel the probe cover 22 has moved away from the probe 18, the sensor 30 will detect an increase in the amount of radiation emitted by emitter 28. The amount of such radiation detected will correspond With the amount of radiation originally detected by the sensor 30, prior to mounting the probe cover 22 onto the head section 16 and ove the probe 18. [00241 Although the emitter 28 is shown as being mounted on the head section 16, it should he appreciated that. the emitter 28 may be sitmated at a variety of locations, and need not be monteI on the head sec 16ti 6 [0025] IGS 5. 6. and 7 ilusitae dhferent se nsor configurations and positions that n b u tlized in coi nnection wit h a preferred embodimn) t of the invention..As stown in IG. 5, the sensor 30a possesses a sqare nniiguration and is simated near to the large end of the probe 18. In FG. 6 the sensor 30b is fa.hioned in the shape of an elongate strip getneraly extending in a (ngirudinak di recnon relative to dhe pr'obe: 18 and extending from te small end thereof to approximuey the incpoint longitudinally along the pIro'b 18. In IG. 7 the sensor 30c cormprises an array of circular scnor clernts mounted icar the sinaller Cd of tle proe 18. Preferably the sensors 30a, 30b, 30c are oriented such that they directly face the emitter 28. [0026] In use, the sensor 3) first determinies whether the probe cover. 22 has been ntmiunted on the head section 16. As shown in FIG. 8, the senrso 30 rnay be operatively connected to a microprocessor 32, which may comain a rimer, and which may cause a signal getneraor 34 to display the amount of imc that has laped since the pinke cover 22 has been motried on the head seetioi 16. A healthcare practi owner operating rhe oosetcpe In rnay realize from the amount of timc displayed 9 WO 2011/090670 PCT/US2010/061715 that the probe cover 22 probably has been used and shtoulId be discarded, or, as jusi a precaionry measure, the probe cnver 22 should he discarded. [00271 The invention also conteimplats that the microproces so 32 will be programmed to wait a predetermined time interval, such as Ave seconds, after the sensor 30 first senses hat the amount of radiation sensted indicates that be prhe cover 22 has been noumed over the probe I8 to register tie even when the parh cover 22 has been mounted. Such a time interval will help insure that tihe probe cover 22 is riot simply in the process of being Imountedhut in fact. has been mounted, over the probe 18 and is attached to thi head section 16. In another embodiment, the nicroprocessor 32 may be programmed to register that the probe cover 22 is mounted oin tie head section 16 only afher a predetermined time interval, such as fe seconds, contitously shows that the arnonut of radiation sensed by sensor 30 corresponds with the probe cover 22 hAving been mounted over the probe 18. As an additional feature of the invention. the m microprocessor 32 riay be prograniiimed so as to stoutid an audio alarm, or to provide a blinking light Signal, via the signal generator 34 f a preetetrlined timin terval, sich As rive m iiutest, h iaS'ccu after the enor 30 first idiicates thIt rhe probe covet CO lir 2 has e nunted the hlad secttin 16. The microp rtoestor 32 would be programmed not to cause sucII signals to lie genilera:ted if the sensor 30 senses in amount of radiation that indicates that the probe cover 22 has beiei removed frm te head section 16 and away from the probe I dur-ing that dme interval. [0028] I he present inve ntion cotempates tat dic enitter 28. such as a blue L"ID, might automlatically provide visual illuninationi i na C ontn iaus aner Ipo n reioval of the otoscope 10 from a storage housing. AKernatively, as shown in IG. 8, a switch 36 may be used to selectively activare and deactivate the emitre 28 ]in such a niode of operation, the cnititler 28 may help- a iealthcare pracitioner find probe Covers, die patient's ntrifice, and otier objects in a dark envionmnt i1 o there 10 WO 2011/090670 PCT/US2010/061715 emibodimi en ts of the pesenr invention, the microprocessor 32 could disable the light sounce within the head section 16 fromn projecting ig18 tales he sensor 30 detects an ainWfIt of raadiion that indicates thar a probe cover 22 is not mounted on the head section 16 or has not been removed a after a prCdetermined tine intevaA. In yi another cmbodiieiti., whereO te medical instrumen t is an infrared t hermomerer, the micioprocessor 32 could prevent the thermomeiter front taking any remperture readings unless the scinsor 30 senses an amout of radiation that indicates a probe cover 22 is mounted on the i head section 16, siiliarly, the microprocessor 32 could prevent the infrand thermometer from n making a temperature reading if, within a predeterinncd dime interval after i the pIob cove 22 has heen mounnoted over the probe 18, the sensor30 does not sense an amount of radiation emitted by the emitter 28 that indicates the probe cover 22 h hrs been Lillounited from the bead section 16 and removed away from the probe 1.8. [0029] 11. should Aso be appreciate that the preseniti invCent0o n May be use ful in connection whit determining the depth of insertion of the probe 18 and any associated probe cover 22 into an office of a body. With special reference to FIG& 4, 6, and 7, if the sensor 30b 30c is disposed in the orifice near the walls of the orifice, then radiation emitted by emitter 28 will be substantially blocked or occluded Iron reaching th sensor 301, 30c. Such blockage or OCClusion Will decrees e the amount of radiation snClscd by the sensor 30, which may he corlelated with a particular depth of inserion of the small end of the probe I8 or rh probe (cver 22 within the i ine. In nie emboimei, there is a linacar correlation biteiteCen the deCree of reni:duction of sensed ratdi atiott xwit I tlhte depth of insertion . In the case of an inf rared teriomneter, the microprocessor 32 may be prograitned to prevent a tem perature rea ding if the depth of insertin is insufficient. Also, the recogniion by the rnicropricessor 32 that the probe 18 and any associated probe cover 22 has been inserted into the orifice may be used to prompt the micropocessor 32 to cause te 11 signal generator 34 to generate an audio or visual signal or to prevent re-use of the medical instrument, such as by disabling the light source in the head section 16 in an otoscope, or by disabling the temperature reading function of an infrared thermometer, if a pre-determined time interval has passed and the sensor 30 does not indicate that the probe cover 22 has been removed. In this regard, the switch 36 may be a multi-position switch with including one position to activate or deactivate the emitter 28, and another position to activate the insertion depth function. [0030] While exemplary embodiments have been presented in the foregoing description of the invention, it should be appreciated that a vast number of variations within the scope of the invention may exist. The foregoing examples are not intended to limit the nature or the scope of the invention in any way Rather, the foregoing detailed description provides those skilled in the art with a foundation for implementing other exemplary embodiments of the invention. [0031] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. [0032] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as, an acknowledgement or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. -12-

Claims

1. A medical instrument including: a support structure; a probe attached on said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; a probe cover adapted to be selectively mounted over and to substantially cover said probe and said sensor, said probe cover being partially transparent to said radiation such that when said probe cover substantially covers said probe, said sensor senses reduced transmittance of said radiation; and a microprocessor operatively connected to said sensor, said microprocessor configured to monitor the magnitude of said radiation sensed by said sensor and to evaluate the degree of any reduction of said monitored magnitude as an indication of the insertion of said probe into the body orifice.

2. A medical instrument according to claim 1 wherein said emitter comprises a blue LED and wherein said radiation possesses a strong intensity in the bandwidth substantially in the range of about 500-550 nanometers.

3. A medical instrument according to claim 1 wherein said probe cover transmits between about 40-60 percent of said radiation impinging thereon within a selected bandwidth. 13

4. A medical instrument according to claim I wherein said probe cover is coated with a material that blocks a substantial position of said radiation within a selected bandwidth from passing therethrough.

5. A medical instrument according to claim 1 wherein said probe cover possesses a substantially frusto-conical configuration.

6. A medical instrument according to claim 1 wherein said medical instrument consists essentially of an ear instrument.

7. A medical instrument according to claim 1 wherein said medical instrument consists essentially of an infrared thermometer.

8. A medical instrument according to claim 1 wherein said probe extends in a substantially longitudinal direction and possesses an outer exterior surface, wherein said sensor extends in a substantially elongate, longitudinal direction along said outer peripheral surface of said probe and whereby when said probe is inserted into the orifice, said radiation is partially blocked by the walls of the orifice from reaching said sensor and as said probe is inserted deeper into the orifice even more of said radiation is blocked by the walls of the orifice from reaching said sensor.

9. A medical instrument according to claim 8 wherein said microprocessor is configured to calculate a depth of insertion of said probe into the orifice in a substantially linear relationship with the decrease in the magnitude of said radiation sensed by said sensor.

10. A medical instrument according to claim 9 wherein said microprocessor is further programmed to determine that a pre-determined depth of insertion constitutes a preferred position of said probe, wherein said medical instrument 14 further comprises a signal generator operatively connected to said microprocessor adapted to signal whether the pre-determined depth is attained.

11. A medical instrument according to claim 10 wherein said signal generator is selected from the group consisting of a visual display screen, a sound alarm, and a visual light.

12. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, comprising: (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; (4) a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; and (5) a probe cover adapted to be selectively mounted over and to substantially cover said probe, said probe cover being partially transparent to said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) monitoring the magnitude of said radiation sensed by said sensor; (e) establishing a threshold magnitude of said radiation; (f) setting a threshold time interval; and 15 (g) determining that said probe cover is mounted over and substantially covers said probe if said monitored magnitude of said radiation is no more than said threshold magnitude during said threshold time interval.

13. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 12, further comprising: (h) if it is determined that said probe cover has been mounted over and substantially covers said probe, then making a later determination of whether the magnitude of said radiation sensed by said sensor increases by a magnitude that would indicate that such probe cover has been unmounted from a disposition mounted over and substantially covering said probe.

14. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 13, further comprising: waiting a pre-determined time interval after the earlier determination that said probe cover has been mounted over and substantially covers said probe before making said later determination.

15. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 13 further comprising: generating a signal if the later determination indicates that the magnitude of said radiation sensed by said sensor is not increased by a magnitude that would indicate that said probe cover has been unmounted from a disposition mounted over and substantially covering said probe within a predetermined time interval after the earlier determination indicates that said probe cover has been mounted over 16 and substantially covers said probe, said signal selected from the group consisting of a visual display screen, a sound alarm, and a visual light.

16. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 13 wherein said medical instrument comprises an infrared thermometer in which the probe thereof is adapted to be inserted into an ear and further comprising preventing said thermometer from reading a temperature if the later determination indicates that the magnitude of said radiation sensed by said sensor is not increased by a magnitude that would indicate that said probe cover has been unmounted from a disposition mounted over and substantially covering said probe within a predetermined time interval after the earlier determination indicates that said probe cover has been mounted over and substantially covers said probe.

17. A method of determining the depth of insertion of a probe of a medical instrument into an orifice of a body, comprising: (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe possessing an outer peripheral surface and adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said outer peripheral surface of said probe, said emitter mounted on said support structure; (4) a sensor adapted to sense said radiation, said sensor mounted on said outer peripheral surface of said probe in a position so as to receive said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) determining the magnitude of said radiation sensed by said sensor; 17 (e) inserting said probe into the orifice; (f) monitoring the magnitude of said radiation sensed by said sensor as said probe is inserted into the orifice; and (g) evaluating whether the degree of any reduction of said monitored magnitude as said probe is inserted into the orifice indicates the extent to which said sensor has passed a wall of the orifice.

18. A method of determining the depth of insertion of a probe of a medical instrument into an orifice of a body according to claim 17 further comprising: determining the depth of insertion of said probe into the orifice based upon said evaluation.

19. A method of determining the depth of insertion of a probe of a medical instrument into an orifice of a body according to claim 17 wherein said probe extends in a substantially longitudinal direction and wherein said sensor extends in a substantially elongate, longitudinal direction along said outer peripheral surface of said probe.

20. A method of determining the depth of insertion of a probe of a medical instrument into an orifice of a body according to claim 17 wherein said sensor comprises an array of sensor elements mounted on said probe.

21. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, comprising: (a) providing a medical instrument including: (1) a support structure; (2) a probe attached to said support structure, said probe adapted to be inserted into an orifice in an animal's body; (3) an emitter that emits electro-magnetic radiation toward said probe, said emitter mounted on said support structure; 18 (4) a sensor adapted to sense said radiation, said sensor mounted on said probe in a position so as to receive said radiation; and (5) a probe cover adapted to be selectively mounted over and to substantially cover said probe, said probe cover being partially transparent to said radiation; (b) emitting said radiation from said emitter; (c) sensing said radiation with said sensor; (d) determining the magnitude of said radiation sensed by said sensor; (e) assessing whether the magnitude of said radiation sensed by said sensor drops by a magnitude that would indicate that said probe cover has been mounted to substantially cover said probe; and (f) if the magnitude assessment indicates that said probe cover has been mounted to substantially cover said probe, then making a later magnitude assessment of whether the magnitude of said radiation sensed by said sensor increases by a magnitude that would indicate that such probe cover has been unmounted from a disposition substantially covering said probe.

22. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 21, further comprising: waiting a pre-determined time interval after the earlier magnitude assessment indicates that said probe cover has been mounted to substantially cover said probe before making said later magnitude assessment.

23. A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 21 further comprising: 19 generating a signal if the later magnitude assessment indicates that the magnitude of said radiation sensed by said sensor does not increase by a magnitude that would indicate that said probe cover has been unmounted from a disposition substantially covering said probe within a predetermined time interval after the prior radiation magnitude assessment indicates that said probe cover has been mounted to substantially cover said probe, said signal selected from the group consisting of a visual display screen, a sound alarm, and a visual light.

24 A method of determining the condition of a probe cover adapted to substantially cover a probe, which is adapted to be inserted into an orifice in an animal's body, according to claim 21 wherein said medical instrument comprises an infrared thermometer in which the probe thereof is adapted to be inserted into an ear and further comprising preventing said thermometer from reading a temperature if the later magnitude assessment indicates that the magnitude of said radiation sensed by said sensor does not increase by a magnitude that would indicate that said probe cover has been unmounted from a disposition substantially covering said probe within a predetermined time interval after the earlier magnitude assessment indicates that said probe cover has been mounted to substantially cover said probe. 20